The Korean government has undertaken significant steps to streamline the regulatory process, and is committed to continuous harmonization with global standards. Important regulatory reforms include the implementation of GCP guidelines (from 1995), the introduction and separation of IND from the NDA review process (in 2002), a reduction of the IND approval timeline to 30 working days, and support for participation in multi-regional clinical trials.

These regulatory reform efforts are ongoing and now include a shorter 14-day review for healthy volunteer studies (than 30 days previously), and the acceptance of clinical protocols in English for phase 1 studies. The IRB approval process typically occurs in parallel to an MFDS review, with busy sites holding IRB meetings on a weekly basis.

Korea’s public healthcare system also ensures reimbursement for most medical expenses, such that an estimated 97% of the 51 million population benefits from healthcare coverage via the national insurance system.

Major university hospitals are generally larger than 1,000 beds and receive as many as 10,000 or more outpatients a day. Designated clinical trial centers (CTCs) affiliated with these hospitals have access to a large and diverse patient pool and benefit from rapid patient recruitment. Accordingly, Korean CTCs are widely recognized as among the fastest patient recruitment sites in the world, and boast relatively low drop-out rates during the conduct of clinical trials.

Korea’s CTCs are home to world-class facilities and infrastructure, while an outstanding oversight of quality control, staff management and development ensures the successful conduct of patient as well as healthy volunteer clinical trials.

Furthermore, there are over 170 clinical trial sites inspected and certified by the Korea Ministry of Food and Drug Safety (MFDS, formerly KFDA). According to the US FDA, which has conducted due diligence in Korea since 2008, Korea maintains a perfect record with no major official actions recorded for any clinical or non-clinical trials.

Last but not least, Korean investigators regularly receive intensive GCP training in these major hospitals nationwide.

Click the icon below to view a short video clip introducing the KoNECT Collaboration Center for clinical trials.